PRMRP-Norms: Iterative Design of Custom Dynamic Orthoses
Study Details
Study Description
Brief Summary
The proposed study evaluates the effect of carbon fiber brace design on forces across the ankle joint. It is expected that carbon fiber braces can be designed to reduce forces in the ankle. In this study, brace geometry will be varied to determine how these changes influence the forces experienced by ankle cartilage. The purpose of this study is to refine a pre-existing musculoskeletal model and finalize the procedures for inputting multiple data sources into the model to evaluate ankle articular contact stresses.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The purpose of this study is to refine a pre-existing musculoskeletal model and finalize the procedures for inputting multiple data sources into the model to evaluate ankle articular contact stresses.
Healthy adult participants will complete testing using three generic sized carbon fiber custom dynamic orthoses (CDOs) and with no CDO. Participants will be blinded to the design variation of each device and will only know them as CDO-A, CDO-B, or CDO-C. Testing will be completed under 4 conditions: No-CDO, CDO-A, CDO-B, CDO-C, with each bracing condition (A/B/C) representing a CDO design variant. Physical performance measures will incorporate tests of agility, speed, and lower limb power to ensure that changes to device design do not negatively affect physical function. Questionnaires will be used to evaluate participants' current and desired activity level, pain with and without CDO use, satisfaction with the devices, perception of comfort and smoothness between devices, and preference between CDOs. Semi-structured interviews will be completed to fully capture the participant's perspective. Lower limb forces and motion will be assessed using a computerized motion capture system and force plates in the floor. Forces between the foot and CDO will be measured using force sensing insoles, and muscle activity data will be collected using surface electromyography. Devices will be mechanically tested, and participant demographic and anthropometric data will be recorded.
The information obtained from this study will help refine the musculoskeletal model data input methods to be used in future studies. The knowledge that will be gained from this investigation has the potential to substantially improve the long-term efficacy and efficiency of the musculoskeletal model and help improve ankle foot orthosis
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: NoCDO Participants will be evaluated without a CDO. |
|
| Experimental: CDO-A The first design variant will be designated CDO-A. |
Device: Carbon Fiber Custom Dynamic Orthosis (CDO)
The CDO will consist of a semi-rigid foot plate, a posterior carbon fiber strut, and a proximal cuff below the knee.
Other Names:
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| Experimental: CDO-B The second design variant will be designated CDO-B. |
Device: Carbon Fiber Custom Dynamic Orthosis (CDO)
The CDO will consist of a semi-rigid foot plate, a posterior carbon fiber strut, and a proximal cuff below the knee.
Other Names:
|
| Experimental: CDO-C The third design variant will be designated CDO-C. |
Device: Carbon Fiber Custom Dynamic Orthosis (CDO)
The CDO will consist of a semi-rigid foot plate, a posterior carbon fiber strut, and a proximal cuff below the knee.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Joint Contact Stress Exposure (Model estimated) [Baseline]
Joint contact stress exposure (MPA-s/gait cycle) will be estimated using a participant specific musculoskeletal model.
Secondary Outcome Measures
- Four Square Step Test (4SST) [Baseline]
The 4SST (s) is a standardized timed test of balance and agility.
- Sit to Stand 5 Times (STS5) [Baseline]
STS5 (s) is a well-established timed measure of lower limb muscle strength and power. Participants are instructed to stand up and sit down 5 times as fast as possible.
- Ankle Range of Motion [Baseline]
Ankle range of motion (degrees) during gait.
- Peak Ankle Moment [Baseline]
Peak ankle moment (Nm/kg) during gait.
- Peak Ankle Power [Baseline]
Peak ankle power (W/kg) during gait.
- Center of pressure velocity timing [Baseline]
Timing of peak center of pressure velocity (percent stance) during gait.
- Center of pressure velocity magnitude [Baseline]
Magnitude of peak center of pressure velocity (m/s) during gait.
- Soleus Muscle Activity (Electromyography) [Baseline]
Electromyography (EMG, % Maximum) of the Soleus during gait.
- Tibialis Anterior Muscle Activity (Electromyography) [Baseline]
Electromyography (EMG, % Maximum) of the Tibialis Anterior during gait.
- Medial Gastrocnemius Muscle Activity (Electromyography) [Baseline]
Electromyography (EMG, % Maximum) of the Medial Gastrocnemius during gait.
- Rectus Femoris Muscle Activity (Electromyography) [Baseline]
Electromyography (EMG, % Maximum) of the Rectus Femoris during gait.
- Vastus Medialis Muscle Activity (Electromyography) [Baseline]
Electromyography (EMG, % Maximum) of the Vastus Medialis during gait.
- Plantar Force [Baseline]
Force data (N) collected from the hind foot, mid foot, and forefoot, measured between the foot and orthosis during gait.
Other Outcome Measures
- The Orthotics Prosthetics Users' Survey (OPUS) [Baseline]
Satisfaction with device will be assessed using the Orthotics Prosthetics Users' Survey Satisfaction With Device Score (11-55). Lower scores indicate a better outcome.
- Modified Socket Comfort Score (Comfort and Smoothness) [Baseline]
Comfort scores range from 0 = most uncomfortable to 10 = most comfortable, and from 0 = least smooth to 10 = most smooth.
- Numerical Pain Rating Scale [Baseline]
Pain will be assessed using a standard 11-point numerical pain rating scale, in which 0 = no pain and 10 = worst pain imaginable.
- Participant Device Preference [Baseline]
The participant will rank order their preference for their standard of care device (if applicable), No Device, CDO-A, CDO-B, CDO-C on a questionnaire.
- Semi-Structured Interview [Baseline]
Semi-structured interviews will also be used to fully capture the patients' perspectives, experience, and opinions associated with the device options they experienced as part of the study.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Between the ages of 18 and 50
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Shoe size between women's 8 and 13.5 or men's 6.5 and 12
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Healthy individuals without a current complaint of lower extremity pain, spine pain, or medical or neuromusculoskeletal disorders that have limited participation in work or exercise in the last 6 months
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Full active range of motion of the bilateral lower extremities and spine
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Ability to hop without pain
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Ability to perform a full squat without pain
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Ability to read and write in English and provide written informed consent
Exclusion Criteria:
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Diagnosed moderate or severe brain injury
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Prior lower extremity injury resulting in surgery or limiting function for greater than 6 weeks
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Diagnosis of a physical or psychological condition that would preclude testing (e.g. cardiac condition, clotting disorder, pulmonary condition)
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Visual or hearing impairment that would interfere with instructions given during testing
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Require an assistive device
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Wounds to the foot or calf that would prevent CDO use
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BMI greater than 35
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Pregnancy - Per participant self-report. Due to the expected small number of pregnant individuals and resulting inability to account for its effect on resulting outcomes, participants will be withdrawn from the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The University of Iowa | Iowa City | Iowa | United States | 52242 |
Sponsors and Collaborators
- University of Iowa
Investigators
- Principal Investigator: Jason M Wilken, PT, PhD, University of Iowa
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 202002131